Insomnia Treatment and Problems (the iTAP Study)

NCT ID: NCT03627832

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-29
• Study Completion Date: 2019-09-27

Brief Summary

This project aims to evaluate the efficacy of insomnia treatment in improving insomnia symptoms and alcohol-related problems among heavy-drinking young adults.

Detailed Description

Heavy alcohol use is prevalent among young adults and results in significant physical and psychological burden. Despite wide implementation of alcohol risk reduction efforts on college campuses, rates of heavy alcohol consumption remain high, with 35% of students reporting consumption of 5+ drinks on the same occasion in the past 2 weeks. Thus, additional strategies are needed to reduce the burden of heavy alcohol use among college students. More than half of heavy-drinking college students report symptoms of insomnia. In turn, insomnia symptoms have been associated with increased risk of alcohol-related problems. The proposed project aims to reduce the burden of heavy alcohol use on college campuses by examining the efficacy of Cognitive Behavioral Therapy for Insomnia (CBT-I) in reducing alcohol use and related problems among heavy-drinking college students. Twenty seven young adults who indicate risk for problem drinking and meet DSM-5 criteria for Insomnia Disorder will participate in a 5-week pilot trial. Participants will complete five individual sessions of CBT-I. Outcomes will be assessed at the end of the active intervention period (6 weeks) and 1 month post-intervention. Outcomes of interest include insomnia severity, total wake time, sleep quality, drinking quantity, and alcohol-related consequences. The proposed research aims to reduce the harms associated with heavy alcohol use among young adults by improving the availability of efficacious treatment. It will impact understanding of the benefits of CBT-I, and it is innovative because it evaluates improvement in insomnia as a mechanism for improvements in alcohol use disorder (AUD). This research is consistent with the National Institute on Alcohol Abuse and Alcoholism's initiative to evaluate and promote interventions that prevent the progression of AUD in diverse populations. It will enhance the stature of the university by improving our ability to compete successfully for federal funding to conduct high-quality research.

Conditions

Insomnia; Alcohol; Harmful Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CBT-I

Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for 6 weeks

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Intervention Type: BEHAVIORAL

Participants assigned to the CBT-I condition will attend 1-hour individual sessions of CBT-I once a week for five weeks. Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, \& Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.

Sleep Hygiene

Intervention Type: BEHAVIORAL

All participants will receive a one-page handout on sleep hygiene. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.

Sleep Hygiene

Sleep hygiene handout delivered once to all participants

Group Type: ACTIVE_COMPARATOR

Sleep Hygiene

Intervention Type: BEHAVIORAL

All participants will receive a one-page handout on sleep hygiene. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.

Interventions

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Participants assigned to the CBT-I condition will attend 1-hour individual sessions of CBT-I once a week for five weeks. Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, \& Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.

Intervention Type: BEHAVIORAL

Sleep Hygiene

All participants will receive a one-page handout on sleep hygiene. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 18-30 years
• Heavy episodic drinking, defined as 1 heavy drinking episode (4/5+ drinks for women/men) in the past 30 days on the Timeline Followback
• DSM-5 criteria for insomnia, with "daytime impairment" operationalized as ISI scores =>10

Exclusion Criteria

• Unable to provide informed consent
• New sleep medication in the past 6 weeks
• Contraindications for CBT-I (mania or seizure disorder)
• Severe psychiatric disorder that requires clinical attention (PTSD, major depression)
• Current treatment for insomnia or alcohol use

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Mary E Miller

Professor, Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Beth Miller, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University of Missouri-Columbia

Columbia, Missouri, United States

Countries

United States

References

Miller MB, Carpenter RW, Freeman LK, Curtis AF, Yurasek AM, McCrae CS. Cannabis use as a moderator of cognitive behavioral therapy for insomnia. J Clin Sleep Med. 2022 Apr 1;18(4):1047-1054. doi: 10.5664/jcsm.9796.

Reference Type: DERIVED

PMID: 34870584 (View on PubMed)

Miller MB, Curtis AF, Hall NA, Freeman LK, Everson AT, Martinez LD, Park CJ, McCrae CS. Daily associations between modifiable sleep behaviors and nighttime sleep among young adult drinkers with insomnia. J Clin Sleep Med. 2022 Mar 1;18(3):703-712. doi: 10.5664/jcsm.9706.

Reference Type: DERIVED

PMID: 34605392 (View on PubMed)

Miller MB, Freeman LK, Deroche CB, Park CJ, Hall NA, McCrae CS. Sleep and alcohol use among young adult drinkers with Insomnia: A daily process model. Addict Behav. 2021 Aug;119:106911. doi: 10.1016/j.addbeh.2021.106911. Epub 2021 Mar 15.

Reference Type: DERIVED

PMID: 33773200 (View on PubMed)

Miller MB, Deroche CB, Freeman LK, Park CJ, Hall NA, Sahota PK, McCrae CS. Cognitive behavioral therapy for insomnia among young adults who are actively drinking: a randomized pilot trial. Sleep. 2021 Feb 12;44(2):zsaa171. doi: 10.1093/sleep/zsaa171.

Reference Type: DERIVED

PMID: 32886778 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

DXV15

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2010684

Identifier Type: -

Identifier Source: org_study_id